Research in any field is done with an aim of inventing solutions for various situations based on the field of specialty. In clinical research, scientists work to come up with new and better methods of disease prevention and treatment. It also serves to provide temporary solutions to ensure that patients are kept comfortable while definitive treatment is in the process of being established. In this article we discuss details about clinical research Tampa residents may find meaningful.
Before a drug is put on trial, it has to undergo certain processes to ensure it is safe for use in test subjects. Such processes will determine characteristic features of a potential drug including its absorption, distribution, metabolism and excretion from the body. This is referred to as the pharmacokinetics of the drug. Pre-clinical studies also try to find out the pharmacodynamic nature of the substance in question. Pharmacodynamics refer to the reaction of the body to the drug including its desired and adverse side effects. At the end of a pre-clinical study, researchers are in a position to decide just how much of the drug can be tolerated by a given individual.
In some instances, medical equipment is usually the one undergoing scientific studies to facilitate diagnosis and treatment of disease. In this case, the device does not need to go through the initial pre-clinical phase as drugs do. Medical devices instead are taken through what is good laboratory practices with the aim of ascertaining whether the equipment is sustainable in the human body and just how safe it is for use.
Phase zero of clinical research is meant to speed up the trial process. It is, however, not considered a platform for testing the safety and toxicity profile of a drug. This is because very small concentrations of the agent are introduced in animal models. The exercise is usually done at a small scale. The ultimate goal is to rule out or rule in the possibility of the agent proceeding to the next stage.
Phase one of the trial is like the pre-clinical phase only that this time round human beings are used instead of animals. The number of subjects ranges from two to a hundred. This stage takes time to evaluate the dose that is needed to cause desired effect. It is at this stage that the best formulation is decided upon. Safety and toxicity is an additional concern.
Usually, healthy persons are used for study. The disadvantage is that these individuals may get sick in the process. Therefore, such people participate at a fee and informed consent is part of preparation. Alternatively, patients who are suffering from certain conditions and have not responded to all the available treatments in the market can sign up for such trials. Another category is that of patients with terminal illnesses.
Phase two of research requires the participation of more than a hundred people. This phase mainly tests for efficacy of a drug on a larger number of individuals. The third phase calls for more than a hundred individuals to participate. It is an intensive phase that seeks to prove the value of a therapeutic agent.
Last but not least is the fourth phase which aims to refine the research to assess special areas such as drug interactions involving the new molecule. It also assesses pregnant women and the young age group. This is attributed to the fact that these fall in the bracket of extremely high risk groups.
Before a drug is put on trial, it has to undergo certain processes to ensure it is safe for use in test subjects. Such processes will determine characteristic features of a potential drug including its absorption, distribution, metabolism and excretion from the body. This is referred to as the pharmacokinetics of the drug. Pre-clinical studies also try to find out the pharmacodynamic nature of the substance in question. Pharmacodynamics refer to the reaction of the body to the drug including its desired and adverse side effects. At the end of a pre-clinical study, researchers are in a position to decide just how much of the drug can be tolerated by a given individual.
In some instances, medical equipment is usually the one undergoing scientific studies to facilitate diagnosis and treatment of disease. In this case, the device does not need to go through the initial pre-clinical phase as drugs do. Medical devices instead are taken through what is good laboratory practices with the aim of ascertaining whether the equipment is sustainable in the human body and just how safe it is for use.
Phase zero of clinical research is meant to speed up the trial process. It is, however, not considered a platform for testing the safety and toxicity profile of a drug. This is because very small concentrations of the agent are introduced in animal models. The exercise is usually done at a small scale. The ultimate goal is to rule out or rule in the possibility of the agent proceeding to the next stage.
Phase one of the trial is like the pre-clinical phase only that this time round human beings are used instead of animals. The number of subjects ranges from two to a hundred. This stage takes time to evaluate the dose that is needed to cause desired effect. It is at this stage that the best formulation is decided upon. Safety and toxicity is an additional concern.
Usually, healthy persons are used for study. The disadvantage is that these individuals may get sick in the process. Therefore, such people participate at a fee and informed consent is part of preparation. Alternatively, patients who are suffering from certain conditions and have not responded to all the available treatments in the market can sign up for such trials. Another category is that of patients with terminal illnesses.
Phase two of research requires the participation of more than a hundred people. This phase mainly tests for efficacy of a drug on a larger number of individuals. The third phase calls for more than a hundred individuals to participate. It is an intensive phase that seeks to prove the value of a therapeutic agent.
Last but not least is the fourth phase which aims to refine the research to assess special areas such as drug interactions involving the new molecule. It also assesses pregnant women and the young age group. This is attributed to the fact that these fall in the bracket of extremely high risk groups.
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